Documents
Application Sponsors
| NDA 020908 | NOVO NORDISK INC | |
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;VAGINAL | 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | VAGIFEM | ESTRADIOL |
| 002 | TABLET;VAGINAL | 10MCG | 1 | VAGIFEM | ESTRADIOL |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1999-03-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2000-05-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2000-11-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2001-04-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2001-09-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-07-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-09-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2002-11-06 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2009-11-25 | UNKNOWN |
| LABELING; Labeling | SUPPL | 16 | AP | 2011-05-17 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2012-04-11 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2012-11-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2015-01-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2016-05-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2016-04-04 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2017-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2017-11-01 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2019-04-09 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2022-09-29 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 26 | Null | 6 |
| SUPPL | 27 | Null | 7 |
TE Codes
CDER Filings
NOVO NORDISK INC
cder:Array
(
[0] => Array
(
[ApplNo] => 20908
[companyName] => NOVO NORDISK INC
[docInserts] => ["",""]
[products] => [{"drugName":"VAGIFEM","activeIngredients":"ESTRADIOL","strength":"25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"VAGIFEM","activeIngredients":"ESTRADIOL","strength":"10MCG","dosageForm":"TABLET;VAGINAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"04\/09\/2019","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020908s026lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2017","submission":"SUPPL-25","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020908s025lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2017","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020908s025lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2017","submission":"SUPPL-24","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020908s024lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2012","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020908s017lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2009","submission":"SUPPL-13","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020908s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20908lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"VAGIFEM","submission":"ESTRADIOL","actionType":"25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"VAGIFEM","submission":"ESTRADIOL","actionType":"10MCG","submissionClassification":"TABLET;VAGINAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-04-09
)
)